HIV InfectionsPhase 1NCT00000782
A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
A Phase 1 study testing gp160 Vaccine (Immuno-AG) and gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
To determine the frequency of delayed-type hypersensitivity (DTH) reactions in HIV-positive patients to two doses of two envelope glycoprotein antigens prepared differently. To determine whether patients who have previously demonstrated a DTH response to intradermal MGStage HIV-1 gp160 IIIB baculovirus (MicroGeneSys)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- gp160 Vaccine (Immuno-AG) and gp160 Vaccine (MicroGeneSys)
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Start not givento Oct 1996
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed in Step 2 (PER 4/5/95 AMENDMENT):
- Approved antiretroviral drugs.
- Patients must have:
- Documented HIV infection.
- CD4 count >= 400 cells/mm3.
- NO current active opportunistic infection or neoplasm (other than stable cutaneous Kaposi's sarcoma).
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity to insect proteins.
- Concurrent Medication:
- Excluded:
- Antihistamine or anti-inflammatory medications for the 48-hour period between injection and skin test reading.
Show all 19Show fewer
- Topical steroids.
- Prior Medication:
- PER 4/5/95 AMENDMENT -
- Excluded:
- Prior immunization with experimental HIV vaccines (strata 2 and 3 only).
- Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents within 30 days prior to study entry.
- Antihistamine or anti-inflammatory medications within 72 hours prior to intradermal injections.
- PREVIOUS VERSION -
- Excluded within 30 days prior to study entry:
- Any antiretroviral drugs (other than AZT, ddI, ddC, or d4T for patients in stratum 3).
- Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents.
- Excluded within 72 hours prior to intradermal injections:
- Antihistamine or anti-inflammatory medications.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Stanford CRS
Palo Alto, California, 943055107
Santa Clara Valley Med. Ctr.
San Jose, California, 951282699
San Mateo County AIDS Program
San Mateo, California, 943055107
About this study
To determine the frequency of delayed-type hypersensitivity (DTH) reactions in HIV-positive patients to two doses of two envelope glycoprotein antigens prepared differently. To determine whether patients who have previously demonstrated a DTH response to intradermal MGStage HIV-1 gp160 IIIB baculovirus (MicroGeneSys) have a reproducible response to a repeat injection of gp160 and whether there is cross-reactivity to intradermal HIV-1 rgp160 IIIB vero cell expressed (Immuno-AG).
PER 4/5/95 AMENDMENT: To also determine whether patients who respond to HIV-1 rgp160 IIIB baculovirus (MicroGeneSys) have cross-reactivity to intradermal skin tests of HIV-1 rgp160 MN (Immuno-AG).
Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by vaccination.
Read the detailed description
Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by vaccination.
Patients are stratified into three groups. Fifteen patients previously immunized with MicroGeneSys rgp160 antigen in ACTG 137 and not on antiretroviral therapy will receive intradermal injections of Immuno-AG rgp160 IIIB (vero cell expressed) in one arm, followed 1 week later by intradermal injections of MicroGeneSys rgp160 IIIB (baculovirus expressed) in the opposite arm (stratum 1). Forty patients who are not previously immunized with rgp160 will receive intradermal injections of Immuno-AG gp160 IIIB in one arm simultaneously with MicroGeneSys gp160 IIIB in the opposite arm; these patients are either not on antiretroviral therapy (stratum 2) or currently on antiretroviral therapy (stratum 3). All patients return 48 hours after each injection for skin test reading.
PER 4/5/95 AMENDMENT: Patients on all strata will re-enroll to receive Immuno-AG rgp160 MN in one arm simultaneously with MicroGeneSys rgp160 IIIB in the opposite arm.
- Conditions
- HIV Infections
- Being tested
- gp160 Vaccine (Immuno-AG), gp160 Vaccine (MicroGeneSys)
- Keywords
- Vaccines, Synthetic, Injections, Intradermal, HIV Antigens, HIV-1, HIV Envelope Protein gp160, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed, AIDS Vaccines, HIV Therapeutic Vaccine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp160 Vaccine (Immuno-AG)Biological
gp160 Vaccine (MicroGeneSys)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionOct 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Katzenstein D, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000782
- Sponsor's protocol ID
- ACTG 221
- Other IDs
- 11198
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Katzenstein DA, Kundu S, Spritzler J, Smoller BR, Haszlett P, Valentine F, Merigan TC. Delayed-type hypersensitivity to recombinant HIV envelope glycoprotein (rgp160) after immunization with homologous antigen. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):341-7. doi: 10.1097/00126334-199912010-00004.
PubMed 10634195
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
- ClinicalTrials.gov ID
- NCT00000782
- Acronym / sponsor ID
- ACTG 221
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, Injections, Intradermal, HIV Antigens, HIV-1, HIV Envelope Protein gp160, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 1996 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the frequency of delayed-type hypersensitivity (DTH) reactions in HIV-positive patients to two doses of two envelope glycoprotein antigens prepared differently. To determine whether patients who have previously demonstrated a DTH response to intradermal MGStage HIV-1 gp160 IIIB baculovirus (MicroGeneSys) have a reproducible response to a repeat injection of gp160 and whether there is cross-reactivity to intradermal HIV-1 rgp160 IIIB vero cell expressed (Immuno-AG).
PER 4/5/95 AMENDMENT: To also determine whether patients who respond to HIV-1 rgp160 IIIB baculovirus (MicroGeneSys) have cross-reactivity to intradermal skin tests of HIV-1 rgp160 MN (Immuno-AG).
Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by vaccination.
Detailed description
Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by vaccination.
Patients are stratified into three groups. Fifteen patients previously immunized with MicroGeneSys rgp160 antigen in ACTG 137 and not on antiretroviral therapy will receive intradermal injections of Immuno-AG rgp160 IIIB (vero cell expressed) in one arm, followed 1 week later by intradermal injections of MicroGeneSys rgp160 IIIB (baculovirus expressed) in the opposite arm (stratum 1). Forty patients who are not previously immunized with rgp160 will receive intradermal injections of Immuno-AG gp160 IIIB in one arm simultaneously with MicroGeneSys gp160 IIIB in the opposite arm; these patients are either not on antiretroviral therapy (stratum 2) or currently on antiretroviral therapy (stratum 3). All patients return 48 hours after each injection for skin test reading.
PER 4/5/95 AMENDMENT: Patients on all strata will re-enroll to receive Immuno-AG rgp160 MN in one arm simultaneously with MicroGeneSys rgp160 IIIB in the opposite arm.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Approved antiretroviral drugs.
- Documented HIV infection.
- CD4 count >= 400 cells/mm3.
- NO current active opportunistic infection or neoplasm (other than stable cutaneous Kaposi's sarcoma).
Key exclusion criteria (19 listed)
- Known hypersensitivity to insect proteins.
- Antihistamine or anti-inflammatory medications for the 48-hour period between injection and skin test reading.
- Topical steroids.
- PER 4/5/95 AMENDMENT -
- Prior immunization with experimental HIV vaccines (strata 2 and 3 only).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gp160 Vaccine (Immuno-AG) | Biological | – |
| gp160 Vaccine (MicroGeneSys) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 10634195Katzenstein DA, Kundu S, Spritzler J, Smoller BR, Haszlett P, Valentine F, Merigan TC. Delayed-type hypersensitivity to recombinant HIV envelope glycoprotein (rgp160) after immunization with homologous antigen. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):341-7. doi: 10.1097/00126334-199912010-00004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katzenstein D study chair
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gp160 Vaccine (Immuno-AG) and gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021; AzTrials last refreshed its copy on 29 Oct 2026.